# Focalin XR ### (dexmethylphenidate XR)
**[Full Prescribing Information](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1a1da905-42a0-4748-9c39-67eca45deccc&type=display)**[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a1da905-42a0-4748-9c39-67eca45deccc)
--- **Forms/Strengths** - **Capsules:** 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg --- ### **Dosing** - **Age:** ≥ 6 y/o - **Onset:** ~ 30 min - **Duration:** 8-12 hours - **Release Profile:** 50% IR, 50% ER - **Considerations:** Capsules may be swallowed whole or opened, and the entire contents can be sprinkled on applesauce. - **Initial Dose:** - **New to methylphenidate:** - 6-17 y/o: 5 mg - Adults: 10 mg - **Currently on methylphenidate:** Focalin XR dosage is half (1/2) the current total daily dosage of methylphenidate - **Currently on Focalin IR:** Give the same daily dose of Focalin XR - **Titration:** - 6-17 y/o: 5 mg weekly - Adults: 10 mg weekly - **Max Dose:** - 6-17 y/o: 30 mg/day - Adults: 40 mg/day --- ### **Quick Facts** - Inhibits dopamine/norepinephrine reuptake; enhances focus, attention, and impulse control - Extended-release formulation provides sustained symptom control - Uses SODAS technology for a bi-modal release profile (initial and extended release) - Contains isolated active dextroisomer (dexmethylphenidate), potentially allowing for lower dosing - Common side effects: decreased appetite, insomnia, headache, stomach upset --- ### **Indications** - ADHD** (ICD-10: F90.0) --- ### **Off-Label Uses** - **N/A** --- ### **How to Take** - Take **once daily in the morning** to minimize the risk of insomnia. - Can be taken **with or without food**; high-fat meals may delay absorption. - Swallow the **capsule whole**; do not crush or chew. - If needed, the **capsule can be opened, and contents sprinkled on applesauce**—consume immediately without chewing. --- ### **Side Effects** -
Common: Dry mouth, dyspepsia, headache, anxiety, decreased appetite
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Serious: Cardiac issues, psychiatric symptoms, priapism, peripheral vasculopathy, growth suppression in children
--- ### **Monitoring / Labs** - **Cardiovascular**: Baseline and routine monitoring of heart rate and blood pressure. - **Growth in Pediatrics**: Regular monitoring of height and weight to detect growth suppression. - **Psychiatric Symptoms**: Observe for mood changes, anxiety, or psychosis. - **Abuse Potential**: Monitor for misuse or diversion. --- ### **Education** - **When to Call the Doctor:** - Severe **mood changes, aggression, or suicidal thoughts**. - Chest pain, rapid heartbeat, shortness of breath (**cardiovascular concerns**). - Uncontrolled movements, tics, or worsening anxiety. - Numbness, coldness, or color changes in fingers or toes (**circulatory issues**). - Unexplained weight loss or **delayed growth in pediatric patients**. - **Safety Tips:** - **Monitor blood pressure and heart rate**, especially in patients with cardiovascular risk. - Use caution in patients with **anxiety, bipolar disorder, or psychosis**, as symptoms may worsen. - Avoid **caffeine and other stimulants**, which may amplify side effects. - Ensure **adequate hydration and nutrition**, as appetite suppression is common. - **Tapering may be required** if discontinuing after long-term use. - **Parent Tips for Pediatric Patients:** - **Encourage a nutrient-dense diet** to counteract appetite suppression. - Administer in the **morning before school** for optimal effect. - Monitor **school performance and behavioral changes**. - Observe for **sleep disturbances**; adjust timing if necessary. - Communicate regularly with **teachers and caregivers** about medication effects. --- ### **Additional Information** - **Contraindications:** - **Hypersensitivity** to dexmethylphenidate or formulation components. - **Use within 14 days of MAOI therapy** (risk of hypertensive crisis). - Symptomatic **cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma**. - **History of substance use disorder**, unless benefits outweigh risks. - **Pregnancy:** - **Category C**; use only if benefits outweigh risks. - May cause **neonatal withdrawal symptoms** or **low birth weight**. - **Lactation:** - **Excreted in breast milk**; **not recommended** due to potential infant exposure. - **Drug Interactions:** - **Serotonergic drugs** (e.g., SSRIs, SNRIs, MAOIs) increase **serotonin syndrome risk**. - **Acidifying agents** (e.g., ascorbic acid) may reduce drug absorption. - **Alkalinizing agents** (e.g., sodium bicarbonate) may increase dexmethylphenidate levels. - May potentiate **hypertensive effects** of certain medications (e.g., decongestants, beta-agonists).